PilatesNCT06652282
Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
A study testing Pilates exercises, proprioceptive neuromuscular facilitation and The conventional program in people with Pilates and Proprioceptive Neuromuscular Fascilitation, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Pilates, Proprioceptive Neuromuscular Fascilitation, Shoulder Dysfunction
- What is being tested?
- Pilates exercises, proprioceptive neuromuscular facilitation and The conventional program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range between 40-75 years.
- Only females will participate in the study.
- All patients have no diabetes or blood problems.
- All patients enrolled to the study will have their informed consent
Who cannot join
- Age less than 40 or more than 75 years.
- Diabetes mellitus.
- Subjects suffering from active malignant tumors.
- Subjects treated with skin graft.
- Subjects with Mental illness.
- Subjects with skin diseases
- Subjects with any previous cause for shoulder dysfunction
Trial locations and contacts
1 site in 1 country.
Egypt1 site
out-patient clinic, faculty of physical therapy, Cairo university
Giza
About this study
Official title: Effect of Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy
Read the detailed description
Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.
Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.
Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.
- Being tested
- Pilates exercises, proprioceptive neuromuscular facilitation, The conventional program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.
proprioceptive neuromuscular facilitationOther
Before starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results.
The conventional programOther
Each patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise | Experimental | This group includes 20 patients who had mastectomy and will recieve Pilates exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises), and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability Receives: Other: Pilates exercises |
| proprioceptive neuromuscular facilitation (PNF) | Active comparator | This group includes 20 patients who had mastectomy and will receive PNF exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability Receives: Other: proprioceptive neuromuscular facilitation |
| Conventional exercise | Active comparator | This group includes 20 patients who had mastectomy and will receive conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability Receives: Other: The conventional program |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer
Smartphones can be used as digital goniometers, offering benefits like convenience, ease of measurement, application-based tracking, and one-hand use. These applications use accelerometers to calculate joint angles. Patients with muscle issues, such as abduction and flexion, may experience reduced range of movement due to muscle bulk loss and bony leverage. However, these patients can compensate with the opposite arm, reducing the impact on daily activities.
Measured: at baseline and 3 months
Secondary outcomes (1)
Composite assessment of pain and disability using Shoulder pain and disability index
It i used to determine the shoulder pain and disability. It comprises of 13 items: a 5-item subscale to evaluate the pain and an 8-item subscale to evaluate the disability. The total score is determined by averaging the pain and disability subscale scores.
It exhibits great construct validity, associating admirably with other district explicit shoulder questionnaires
Measured: at baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Nov 2023
- Primary completion1 Mar 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PilatesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Raafat Ahmed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652282
- Sponsor's protocol ID
- Ahmed-005293
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercise Versus Proprioceptive Neuromuscular Facilitation in Shoulder Dysfunction Post Mastectomy
- ClinicalTrials.gov ID
- NCT06652282
- Acronym / sponsor ID
- Ahmed-005293
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study was done to evaluate the therapeutic efficacy of Pilates versus PNF in treatment of shoulder dysfunction and limitation of range of motion after mastectomy
Detailed description
Mastectomy is the removal of the entire breast, with five types: simple or total mastectomy, modified radical mastectomy, radical mastectomy, partial mastectomy, and subcutaneous (nipple-sparing) mastectomy. Post-surgical pain and changes in breast shape can lead to side effects like wound infection, hematoma, seroma, shoulder pain, edema, and decreased range of motion. Mastectomy rates vary worldwide, with the highest rate in central and eastern Europe at 77%. Some women at high risk of breast cancer choose to have a mastectomy even when there's no sign of cancer.
Pilates improve flexibility, build strength, and develop control and endurance in the entire body. It emphasizes alignment, breathing, developing a strong core, and improving coordination and balance. The core, consisting of muscles of the abdomen, low back, and hips, is often called the "powerhouse" and is thought to be the key to a person's stability.
Proprioceptive Neuromuscular Facilitation (PNF) is a stretching technique used to improve muscle elasticity and has been shown to have a positive effect on active and passive range of motions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise | Experimental | Other: Pilates exercisesThis group includes 20 patients who had mastectomy and will recieve Pilates exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises), and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability |
| proprioceptive neuromuscular facilitation (PNF) | Active comparator | Other: proprioceptive neuromuscular facilitationThis group includes 20 patients who had mastectomy and will receive PNF exercise in addition to conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability |
| Conventional exercise | Active comparator | Other: The conventional programThis group includes 20 patients who had mastectomy and will receive conventional physical therapy program (stretching exercises and strengthening exercises) and routine medical treatment. Patients will receive 3 sessions per week for 12 weeks, time of session is 45 - 60 min according to patient ability |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range between 40-75 years.
- Only females will participate in the study.
- All patients have no diabetes or blood problems.
- All patients enrolled to the study will have their informed consent
Key exclusion criteria (7 listed)
- Age less than 40 or more than 75 years.
- Diabetes mellitus.
- Subjects suffering from active malignant tumors.
- Subjects treated with skin graft.
- Subjects with Mental illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates exercisesBefore starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results. | Other | Pilates exercise |
| proprioceptive neuromuscular facilitationBefore starting the training program, patients will learn key Pilates elements, including diaphragmatic breathing, neutral position, rib cage placement, shoulder placement, and head and neck placement. The exercise program includes Pilates-based mat exercises and Pilates-based theraband exercises, with patients placed in supine, prone, and kneeling positions to perform exercises for the affected shoulder. The patient will be placed in various positions for optimal results. | Other | proprioceptive neuromuscular facilitation (PNF) |
| The conventional programEach patient was in the supine position and will receive stretching exercise for the flexors and adductors, and strengthening for the extensors, abductors and scapular stabilizers of the affected shoulder | Other | Conventional exercise |
Primary outcome
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer
Time frame: at baseline and 3 months
Smartphones can be used as digital goniometers, offering benefits like convenience, ease of measurement, application-based tracking, and one-hand use. These applications use accelerometers to calculate joint angles. Patients with muscle issues, such as abduction and flexion, may experience reduced range of movement due to muscle bulk loss and bony leverage. However, these patients can compensate with the opposite arm, reducing the impact on daily activities.
1 secondary outcome
Composite assessment of pain and disability using Shoulder pain and disability index
Time frame: at baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises, proprioceptive neuromuscular facilitation and The conventional program in people with Pilates and Proprioceptive Neuromuscular Fascilitation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the change of shoulder range of motion using Software/Smartphone-based Goniometer (time frame: at baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.